Abstract
In the EMBRACA trial (NCT01945775), TALA significantly improved progression-free survival (HR=0.54; 95% CI: 0.41–0.71; P < 0.001) and quality of life vs physician’s choice of chemotherapy (PCT) while having a manageable safety profile. The most common adverse events (AEs) with TALA were hematologic (68%) but few resulted in permanent discontinuation (<2%). After accounting for the treatment-emergent periods to normalize for longer exposure due to increased efficacy, the serious AE-associated hospitalization rate was lower for TALA vs PCT.
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